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Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

P

Pharmbio Korea

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: PBK-1801

Study type

Interventional

Funder types

Industry

Identifiers

NCT04418388
PBK_1801_101

Details and patient eligibility

About

The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.

Enrollment

36 patients

Sex

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body Mass Index (BMI) between 19 and 30 kg/m²
  • Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
  • Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

Exclusion criteria

  • History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
  • Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
  • History or current alcohol abuse or drug addiction
  • Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

36 participants in 3 patient groups

A
Experimental group
Treatment:
Drug: PBK-1801
B
Experimental group
Treatment:
Drug: PBK-1801
C
Experimental group
Treatment:
Drug: PBK-1801

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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